Starlight Pro and Siliverlight Dental Curing Lights

FDA 510(k) K092951 · Mectron S.P.A.

Substantially Equivalent

510(k) numberK092951

Submission

Device name
Starlight Pro and Siliverlight Dental Curing Lights
Applicant
Mectron S.P.A.
Carasco, IT
Received
September 24, 2009
Decision date
December 7, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EBZ – Activator, Ultraviolet, For Polymerization
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6070
Specialty
Dental

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Questions and answers

When was Starlight Pro and Siliverlight Dental Curing Lights cleared by the FDA?

Starlight Pro and Siliverlight Dental Curing Lights (K092951) received a 510(k) decision of Substantially Equivalent on December 7, 2009, 74 days after the submission was received.

What is the product code of K092951?

The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.